A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Start Date
4/9/2026
Completion Date
11/27/2030
Summary
Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC). A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone. The goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Belzutifan
Zanzalintinib
Placebo
Conditions
Locations
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)
Marietta, Georgia 30060
United States
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0104)
Louisville, Kentucky 40207
United States
Dana Farber Cancer Institute ( Site 0135)
Boston, Massachusetts 02215
United States
Washington University School of Medicine ( Site 0114)
St Louis, Missouri 63110
United States
Atlantic Health System Morristown Medical Center ( Site 0109)
Morristown, New Jersey 07960
United States
Memorial Sloan Kettering Cancer Center ( Site 0126)
New York, New York 10065
United States
The West Clinic, P.C. ( Site 0115)
Germantown, Tennessee 38138
United States
Centro Oncologico Korben ( Site 0254)
CABA, Buenos Aires C1426AHB
Argentina
Hospital Italiano de Buenos Aires ( Site 0253)
Ciudad de Buenos Aires, Buenos Aires 1181
Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)
Mar del Plata, Buenos Aires B7600FZO
Argentina
Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)
Río Cuarto, Córdoba Province X5800ALB
Argentina
Sanatorio Parque ( Site 0251)
Rosario, Santa Fe Province S2000DSV
Argentina
Instituto de Oncología de Rosario ( Site 0257)
Rosario, Santa Fe Province S2000KZE
Argentina
Instituto Alexander Fleming ( Site 0252)
CABA, C1426ANZ
Argentina
Centro Oncológico Riojano Integral ( Site 0256)
La Rioja, X5004BAL
Argentina
COE (Centro Oncológico de Excelencia) ( Site 0259)
San Juan, J5402BGA
Argentina
Macquarie University ( Site 2700)
Macquarie University, New South Wales 2109
Australia
Princess Alexandra Hospital ( Site 2703)
Woolloongabba, Queensland 4102
Australia
Peter MacCallum Cancer Centre ( Site 2702)
Melbourne, Victoria 3000
Australia
Fiona Stanley Hospital ( Site 2704)
Murdoch, Western Australia 6150
Australia
CEDOES ( Site 0303)
Vitória, Espírito Santo 29055-450
Brazil
Instituto do Câncer e Transplante de Curitiba ( Site 0300)
Curitiba, Paraná 80510-130
Brazil
Liga Norte Riograndense Contra o Câncer ( Site 0307)
Natal, Rio Grande do Norte 59062-000
Brazil
Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 0306)
Ribeirão Preto, São Paulo 14026-610
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302)
São José do Rio Preto, São Paulo 15090-000
Brazil
The Ottawa Hospital Cancer Centre ( Site 0003)
Ottawa, Ontario K1H 8L6
Canada
IC La Serena Research ( Site 0405)
La Serena, Coquimbo Region 1720430
Chile
Clínica Puerto Montt ( Site 0404)
Port Montt, Los Lagos Region 5500243
Chile
Fundacion Arturo Lopez Perez ( Site 0401)
Santiago, Region M. de Santiago 7500921
Chile
Bradfordhill ( Site 0400)
Santiago, Region M. de Santiago 8420383
Chile
ONCOCENTRO APYS ( Site 0403)
Viña del Mar, Valparaiso 2520598
Chile
Masarykuv onkologicky ustav ( Site 0903)
Brno, Brno-mesto 656 53
Czechia
Fakultni nemocnice Ostrava ( Site 0904)
Ostrava, Ostrava Mesto 708 52
Czechia
Fakultni nemocnice Hradec Kralove ( Site 0902)
Hradec Králové, 500 05
Czechia
Fakultni nemocnice Olomouc ( Site 0901)
Olomouc, 779 00
Czechia
Fakulti poliklinika ( Site 0906)
Prague, 128 08
Czechia
Fakultni nemocnice v Motole ( Site 0900)
Prague, 150 06
Czechia
Herlev Hospital ( Site 1002)
Herlev, Capital Region 2730
Denmark
Aarhus Universitetshospital, Skejby ( Site 1001)
Aarhus, Central Jutland 8200
Denmark
Centre Antoine Lacassagne ( Site 1209)
Nice, Alpes-Maritimes 06189
France
Hopital Europeen Marseille ( Site 1216)
Marseille, Bouches-du-Rhone 13003
France
LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215)
Toulouse, Haute-Garonne 31059
France
CHU Angers ( Site 1204)
Angers, Maine-et-Loire 49933
France
Clinique Victor Hugo Le Mans-Oncology-Radiotherapy ( Site 1203)
Le Mans, Pays de la Loire Region 72000
France
CHU de Saint-Etienne ( Site 1202)
Saint Priest En Jarez, Pays de la Loire Region 42271
France
Gustave Roussy ( Site 1214)
Villejuif, Val-de-Marne 94800
France
Universitaetsklinikum Augsburg ( Site 1316)
Augsburg, Bavaria 86156
Germany
klinikum rechts der isar der technischen universität münchen ( Site 1315)
Munich, Bavaria 81675
Germany
Universitätsklinikum Jena ( Site 1313)
Jena, Thuringia 07747
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1312)
Berlin, 10117
Germany
Alexandra General Hospital of Athens ( Site 1400)
Athens, Attica 115 28
Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1401)
Athens, Attica 124 62
Greece
Metropolitan Hospital ( Site 1402)
Athens, Attica 185 47
Greece
Rambam Health Care Campus ( Site 1600)
Haifa, 3109601
Israel
Meir Medical Center. ( Site 1603)
Kfar Saba, 4428164
Israel
Rabin Medical Center ( Site 1602)
Petah Tikva, 4941492
Israel
Sheba Medical Center ( Site 1601)
Ramat Gan, 5265601
Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1809)
Meldola, Emilia-Romagna 47014
Italy
Istituto Clinico Humanitas ( Site 1808)
Rozzano, Milano 20089
Italy
Istituto Oncologico Veneto IRCCS ( Site 1806)
Catselfranco Veneto, Padova 31033
Italy
Azienda Ospedaliera Universitaria Careggi ( Site 1807)
Florence, Tuscany 50134
Italy
A.O.U.C. Policlinico di Bari ( Site 1802)
Bari, 70124
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1803)
Bologna, 40138
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1800)
Milan, 20133
Italy
AO Santa Maria della Misericordia ( Site 1805)
Perugia, 06132
Italy
Istituto Nazionale Tumori Regina Elena ( Site 1804)
Roma, 00144
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
Roma, 00168
Italy
Maastricht UMC+ ( Site 1901)
Maastricht, Limburg 6229 HX
Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1900)
Amsterdam, North Holland 1066 CX
Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1903)
Schiedam, South Holland 3118 JH
Netherlands
Haga Ziekenhuis locatie Leyweg ( Site 1906)
The Hague, South Holland 2545 AA
Netherlands
AIDPORT Sp. z o.o. ( Site 2118)
Skórzewo, Greater Poland Voivodeship 60-185
Poland
Pratia MCM Krakow ( Site 2115)
Krakow, Lesser Poland Voivodeship 30-727
Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)
Siedlce, Masovian Voivodeship 08-110
Poland
MTZ Clinical Research Powered by Pratia ( Site 2107)
Warsaw, Masovian Voivodeship 02-172
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 2100)
Warsaw, Masovian Voivodeship 02-781
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2106)
Gliwice, Silesian Voivodeship 44-102
Poland
Severance Hospital, Yonsei University Health System ( Site 2903)
Seoul, 03722
South Korea
Asan Medical Center ( Site 2901)
Seoul, 05505
South Korea
Samsung Medical Center ( Site 2902)
Seoul, 06351
South Korea
Hospital Universitario Virgen del Rocio ( Site 2306)
Seville, Andalusia 41013
Spain
Institut Català d'Oncologia - L'Hospitalet ( Site 2305)
L'Hospitalet de Llobregat, Barcelona 08908
Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2301)
Madrid, Madrid, Comunidad de 28007
Spain
Hospital Universitari Vall d Hebron ( Site 2303)
Barcelona, 08035
Spain
Hospital Insular de Gran Canaria ( Site 2308)
Las Palmas, 35016
Spain
Hospital Universitario 12 de Octubre ( Site 2300)
Madrid, 28041
Spain
Fundación Instituto Valenciano de Oncología ( Site 2307)
Valencia, 46009
Spain
Hacettepe Universite Hastaneleri ( Site 2500)
Sıhhiye, Ankara 06230
Turkey (Türkiye)
Adana Medical Park Seyhan Hastanesi ( Site 2505)
Adana, 01140
Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals ( Site 2506)
Ankara, 06620
Turkey (Türkiye)
Trakya University Medical Faculty Hospital ( Site 2502)
Edirne, 22030
Turkey (Türkiye)
Koc Universitesi Hastanesi ( Site 2501)
Istanbul, 34010
Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 2503)
Izmir, 35080
Turkey (Türkiye)
Addenbrookes Hospital ( Site 2605)
Cambridge, Cambridgeshire CB2 0QQ
United Kingdom
Western General Hospital ( Site 2608)
Edinburgh, Edinburgh, City of EH4 2XU
United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 2602)
Glasgow, Glasgow City G12 0YN
United Kingdom
Leicester Royal Infirmary ( Site 2604)
Leicester, Leicestershire LE1 5WW
United Kingdom
The Christie Hospital NHS Foundation Trust ( Site 2601)
Withington, Manchester M20 4BX
United Kingdom
University Hospitals Birmingham NHS Foundation Trust ( Site 2610)
Birmingham, B15 2GW
United Kingdom
Velindre Cancer Centre ( Site 2612)
Cardiff, CF14 2TL
United Kingdom
University Hospital of Southampton ( Site 2606)
Southampton, SO16 6YD
United Kingdom